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Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure
S E Kenny1, T Irvine, C P Driver
1University of Liverpool, Liverpool, UK. simon.kenny@liv.ac.uk
Insights
Topical glyceryl trinitrate (GTN) paste did not effectively treat acute anal fissures in children. However, a nurse-led program significantly reduced pain and healed fissures in most patients.
Area of Science:
- Pediatric Gastroenterology
- Dermatology
- Pharmacology
Background:
- Anal fissures are common in children, causing significant pain and distress.
- Topical treatments aim to improve blood flow and promote healing.
Purpose of the Study:
- To evaluate the efficacy and safety of topical glyceryl trinitrate (GTN) for acute anal fissures in pediatric patients.
- To compare GTN treatment with a placebo in conjunction with laxative therapy.
Main Methods:
- A randomized controlled trial involving children with acute anal fissures.
- Participants received either 0.2% GTN paste or placebo for six weeks, alongside oral laxatives (senna, lactulose).
- Pain scores and time to painless defecation were assessed weekly by a research nurse.
Main Results:
- No significant difference in pain reduction or time to painless defecation was observed between the GTN and placebo groups.
- Both groups showed significant decreases in pain scores over the 16-week study period.
- No significant differences in fissure healing, bleeding, soiling, or constipation were noted; no serious adverse events occurred.
Conclusions:
- Topical 0.2% GTN paste is not effective for treating acute anal fissures in children.
- A high overall fissure healing rate (84%) was achieved, suggesting the effectiveness of a nurse-supported treatment program.
Aims:
To determine the effectiveness and safety of topical glyceryl trinitrate (GTN) in the management of acute anal fissure in children.
Methods:
Individual children were randomised to receive GTN paste or placebo for six weeks in addition to oral senna and lactulose. Patients took laxatives alone for a further 10 weeks. Each week a research nurse telephoned families to assess pain scores and give advice. Main outcome measures were validated standardised pain scores and time to painless defaecation.
Results:
Forty subjects were recruited from 46 eligible children; 31 children completed the trial (13 in the GTN group and 18 in the placebo group). No differences in the proportion of those achieving pain free defaecation with relation to time were seen between the two groups. Similarly, there were no significant differences in pain scores between the two groups over the 16 week study period. However, in both groups pain scores had decreased significantly. There were no differences in the incidence of rectal bleeding, faecal soiling, presence of visible fissure, skin tag, or faecal loading at outpatient review at the time of recruitment, or at 6 weeks and 16 weeks. No serious adverse effects were observed.
Conclusions:
This study suggests that 0.2% GTN paste is ineffective in the treatment of acute anal fissures in childhood. However the overall fissure healing rate is high (84%) with associated reduction in pain scores, suggesting that a nurse based treatment programme can achieve a high rate of fissure healing.
